BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA SPECTRUM

    MDR report key: 2223316 · Received August 12, 2011

    Report

    Report Number
    2223316
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 31, 2011
    Report Date
    August 11, 2011
    Manufacturer
    SIGMA GENERAL MEDICAL APPARATUS LLC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US

    Narratives

    Description of Event or Problem · 1

    NURSE SET UP PUMP TO DELIVER 150 ML/HR IV SOLUTION FROM IV BAG; PUMP INDICATED IT WAS RUNNING, BUT NO IV SOLUTION WAS INFUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA SPECTRUM INFUSION PUMP FRN SIGMA GENERAL MEDICAL APPARATUS LLC SPECTRUM *

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR OTHER